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Trial registered on ANZCTR


Registration number
ACTRN12624000528550
Ethics application status
Approved
Date submitted
29/11/2023
Date registered
28/04/2024
Date last updated
28/04/2024
Date data sharing statement initially provided
28/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of video laryngoscope-guided D-blade and adult-blade versus standard digital technique for Proseal Laryngeal Mask Airway placement in patient under general anesthesia : a randomized controlled trial
Scientific title
Comparison of fibreoptic score between video laryngoscope-guided D-blade and adult-blade versus standard digital technique for Proseal Laryngeal Mask Airway placement in patient under general anesthesia : a randomized controlled trial
Secondary ID [1] 311059 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participants who underwent elective surgery that need Laryngeal mask airway insertion for ventilate during intra-operative period 332180 0
Condition category
Condition code
Anaesthesiology 328898 328898 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Participants will be randomly allocated to 1 of 3 groups for Proseal LMA insertion:
Group S (control group) - standard digital technique
Group D - under C-MAC laryngoscopic guidance using a D-blade
Group A - under C-MAC laryngoscopic guidance using an adult blade
- In the operating room, standard anesthetic monitoring was applied with electro- cardiogram, non-invasive blood pressure, and peripheral oxygen saturation monitoring.
- Participants will breathe 100% oxygen gas through a face mask for 3 minutes. Induction of anesthesia was carried out with propofol 1.5-2.5 mg/kg intravenous bolus, succinylcholine 0.5 mg/kg intravenous bolus and fentanyl 0.5-1 mcg/kg intravenous bolus. The patients were ventilated with a facemask until conditions were suitable for laryngeal mask airway(LMA) insertion (loss of eyelash reflex, jaw relaxation, and the absence of movement). Additional boluses of 0.5 mg/kg intravenously propofol were given as required until an adequate level of anesthesia was achieved for LMA placement.
- A lubricated LMA was inserted by experienced anaesthetist (who experienced LMA insertion more than 3- times) using the standard digital technique in Group S .under C-MAC laryngoscopic guidance (D-blade) in Group D and under C-MAC laryngoscopic guidance (adult-blade) in Group A. Selection of the LMA size was based on the body weight of the patient. Laryngoscope blade was placed in the vallecula and the epiglottis was identified; then, both the tongue and epiglottis were lifted anteriorly. It was not necessary to visualize the tracheal opening or vocal cords. The LMA was pressed with the index finger and forwarded around the palatopharyngeal curve until the resistance was felt
- After the LMA was inserted, the cuff was inflated with air based on the amount of air proposed by the manufacturing company. With the cuff manometer pressure was set to 60 cmH2O.
- A well-lubricated gastric tube (14 French) was inserted along the drainage tube.
- A fiberoptic scope was passed through the LMA tube and the fiberoptic position was evaluated using the fiberoptic scoring system: 4, only the vocal cords seen; 3, vocal cords plus posterior epiglottis seen; 2, vocal cords plus anterior epiglottis seen; 1, vocal cords not seen.
- During the procedures, anaesthesia was maintained with sevoflurane in air in oxygen keep end-tidal gas (Etgas) 1-1.2 minimum alveolar concentration (MAC)
- At the end of the surgery, all patients received ondansetron 4-8 mg intravenously and removed the LMA after the patient gained consciousness, and collected data on the following adverse events: sorethroat, hoarseness, dysphagia
- Monitor adherence to the intervention by review of anaesthesia records.
Intervention code [1] 327505 0
Treatment: Devices
Comparator / control treatment
a) Control group: Proseal LMA insertion using standard digital technique. The standard digital technique was performed according to the manufacturer’s instructions by pressed with the index finger and forwarded around the palatopharyngeal curve until the resistance was felt. The LMA was inserted by an experienced anesthetist.
Control group
Active

Outcomes
Primary outcome [1] 336708 0
The fiberoptic position score
Timepoint [1] 336708 0
immediately after complete LMA insertion (the capnography tracing was obtained and orogastric tube is inserted)
Secondary outcome [1] 429384 0
First attempt success rate
Timepoint [1] 429384 0
after LMA insertion
Secondary outcome [2] 429385 0
The time taken for LMA insertion
Timepoint [2] 429385 0
the duration from the time the anaesthesiologist picked up the LMA till the capnography tracing was obtained.
Secondary outcome [3] 429386 0
The insertion of the orogastric tube
Timepoint [3] 429386 0
During OG insertion
Secondary outcome [4] 429387 0
Blood pressure change during LMA insertion
Timepoint [4] 429387 0
1, 3, and 5 minutes after LMA insertion.
Secondary outcome [5] 429388 0
postop. complication: blood-stained LMA after remove LMA, sore throat, hoarseness, dysphagia
Timepoint [5] 429388 0
1 hr- post.op at post-anaesthesia care unit (PACU)
24 hr-post op. at in patient department (IPD) ward
Secondary outcome [6] 432412 0
Heart rate change during LMA insertion
Timepoint [6] 432412 0
1, 3, and 5 minutes after LMA insertion.

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status of I-II
Aged between 18 and 65 years
Scheduled for elective surgery in the supine position under general anesthesia using the Proseal LMA for airway management
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with predicted difficult airway (Mallampati score > 2 or mouth opening < 3 cm, BMI > 35 kg/m2),
Pregnant
Patient with oropharyngeal pathology
Patient with co-morbidities: CAD, uncontrolled-HT

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical method in this study starting with pilot study of 12 patients to find value of minimal clinical difference of each group which is 30% , then the value was used to calculated. Sample size 50 per group (total 150 people) was indicated in this study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/08/2023
Date of last participant enrolment
Anticipated
25/08/2024
Actual
Date of last data collection
Anticipated
25/11/2024
Actual
Sample size
Target
150
Accrual to date
35
Final
Recruitment outside Australia
Country [1] 25998 0
Thailand
State/province [1] 25998 0
Bangkok

Funding & Sponsors
Funding source category [1] 315316 0
Hospital
Name [1] 315316 0
King chulalongkorn memorial hospital - Ratchada fund
Country [1] 315316 0
Thailand
Primary sponsor type
Hospital
Name
King chulalongkorn memorial hospital
Address
1873 Rama IV Rd, Khwaeng Pathum Wan, Khet Pathum Wan, Krung Thep Maha Nakhon 10330
Country
Thailand
Secondary sponsor category [1] 317368 0
None
Name [1] 317368 0
Address [1] 317368 0
Country [1] 317368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314238 0
The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand,
Ethics committee address [1] 314238 0
Ethics committee country [1] 314238 0
Thailand
Date submitted for ethics approval [1] 314238 0
04/04/2023
Approval date [1] 314238 0
06/07/2023
Ethics approval number [1] 314238 0
0310/66

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130902 0
Miss Chonchaya Tangnopphapaton
Address 130902 0
King Chulalongkorn Memorial hospital, 1873 Rama IV Rd, Khwaeng Pathum Wan, Khet Pathum Wan, Krung Thep Maha Nakhon 10330
Country 130902 0
Thailand
Phone 130902 0
+66 899493489
Fax 130902 0
Email 130902 0
[email protected]
Contact person for public queries
Name 130903 0
Chonchaya Tangnopphapaton
Address 130903 0
King Chulalongkorn Memorial hospital, 1873 Rama IV Rd, Khwaeng Pathum Wan, Khet Pathum Wan, Krung Thep Maha Nakhon 10330
Country 130903 0
Thailand
Phone 130903 0
+66 899493489
Fax 130903 0
Email 130903 0
[email protected]
Contact person for scientific queries
Name 130904 0
Chonchaya Tangnopphapaton
Address 130904 0
King Chulalongkorn Memorial hospital, 1873 Rama IV Rd, Khwaeng Pathum Wan, Khet Pathum Wan, Krung Thep Maha Nakhon 10330
Country 130904 0
Thailand
Phone 130904 0
+66 899493489
Fax 130904 0
Email 130904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.